Brief description of study

The purpose of this study is to compare relapse-free survival between participants with
FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem
cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after
the time of engraftment for a two year period.

Detailed Study Description

Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing
allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive
gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be
stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced
intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to
randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal
residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.